Over­sight from FDA at phar­ma man­u­fac­tur­ing sites dipped dur­ing 2021 pan­dem­ic

The FDA com­plet­ed less than half (48%) of its reg­u­la­to­ry ac­tions for phar­ma fa­cil­i­ties des­ig­nat­ed as OAI or with an Of­fi­cial Ac­tion In­di­cat­ed, with­in 6 months of an in­spec­tion clos­ing, ac­cord­ing to the lat­est re­port from the agency on the ef­fects Covid-19 had on gen­er­al over­sight at man­u­fac­tur­ing sites last year.

The agency al­so lost pace in is­su­ing fi­nal fa­cil­i­ty clas­si­fi­ca­tion let­ters.

In FY 2021, the re­port not­ed FDA is­sued 70% of fi­nal fa­cil­i­ty clas­si­fi­ca­tion let­ters with­in 90 days of in­spec­tion clos­ing. By com­par­i­son, in FY 2019, 87% of fi­nal fa­cil­i­ty clas­si­fi­ca­tion let­ters were is­sued with­in 90 days of in­spec­tion clos­ing, and com­plet­ed 74% of reg­u­la­to­ry ac­tions for OAI fa­cil­i­ties.

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